ClinicalTrials.gov
ClinicalTrials.gov Menu

Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas (VRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01691027
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The research is aimed at developing and testing a new method of visual-motor rehabilitation of Veterans with macular degeneration by using inexpensive "tablet" computers at home.

Condition or disease Intervention/treatment Phase
Scotoma, Central Central Visual Impairment Behavioral: Visuo-motor training Not Applicable

Detailed Description:

The research objective is to test the hypothesis that practicing eye-hand coordination using tablet-computers can improve manual skills of those with Age-related Macular Degeneration (AMD). AMD causes the loss of sharp central vision used for reading and many other everyday activities. Those with AMD experience a "macular scotoma", a blanked-out area of whatever they're attempting to look at, and they must use an area of peripheral vision, the "Preferred Retinal Locus (PRL)" to look at objects of interest. The PRL does not provide sharp vision, causing deficits in eye-hand coordination needed for manual tasks. There have been few studies of visuo-motor rehabilitation training for deficits caused by macular scotomas. However, a recent study demonstrated that visuo-motor eye movement training dramatically improved reading ability of subjects with AMD. In addition, it has been shown that playing action video games can improve certain visual skills. Thus, a small but growing body of research suggests that it may be possible to ameliorate manual task deficits caused by AMD through computer-based visuo-motor rehabilitation training.

To test this idea, two visuo-motor training modules will be developed for low-cost tablet computers that subjects will use at home. Modules will be for, line and circle tracing, and video games. Both modules will involve PRL-hand coordination by moving a stylus on the tablet screen in response to stimuli. Line and circle tracing will develop eye-hand coordination skills needed for printing. The video game module will provide practice in PRL-hand coordination. Progress in PRL-hand coordination will be automatically recorded on the tablet-computer.

Changes in manual task performance from the training modules will be assessed after each training module using previously developed Scanning Laser Ophthalmoscope (SLO) tests of maze-tracing, and printing. The SLO will also be used to determine the position and fixation stability of the subject's PRL and the retinal position of the scotoma. SLO testing will be repeated three months after all training. Digitized SLO video images showing the hand, stylus, and object on the retina will be measured and analyzed. Several performance measures will be derived from the SLO image analysis including maze-tracing accuracy, printing legibility, retinal area of the stylus, percentage of time the stylus is in the scotoma, and PRL retinal area. This data will be statistically analyzed to determine whether visuo-motor training with the computer tablets improves manual task performance and whether one module is more effective than other.

There will be six groups of five subjects. Subjects will be assigned as they are recruited to a group until the group is full. Two groups will have training delayed by 6 months and will be tested on the SLO 4 times to assess changes in the dependent measure without training. Following training on each module, subject will be tested on maze tracing and printing in the SLO. Two groups undergo four SLO tests without training and begin training six months later.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All eligible subjects trained on three computer-based training modules. SLO assessment of changes in fine manual task performance and in retinal functional geography was done before and after each training module.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visuomotor Rehabilitation Training for Manual Task Deficits From Macular Scotomas
Study Start Date : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Visuo-motor training for low vision
All participants undergo training on scotoma awareness, Line and Circle Tracing and Video games
Behavioral: Visuo-motor training
Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation
Other Names:
  • Scotoma Awareness
  • Line and Circle Tracing
  • Video games (Pong and PacMan)



Primary Outcome Measures :
  1. Improvement in Eye-hand Coordination [ Time Frame: base line, pre-test, post tracing and videogames training ]
    Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination


Secondary Outcome Measures :
  1. Stylus to Eclipse Area [ Time Frame: Base line, Pre and Post training (approximately 3 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral macular scotomas
  • Preferred Retinal Locus (PRL) in at least one eye
  • Visual acuity 20/400 or better in at least one eye
  • No peripheral visual field loss
  • No medications that could affect motor control
  • Normal arm/hand range of motion
  • Pass cognitive ability exam

Exclusion Criteria:

  • No macular scotomas
  • Visual acuity of 20/30 or better
  • Medications that affect motor control
  • Limited arm/hand range of motion
  • Fail cognitive ability exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691027


Locations
United States, Missouri
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: George T Timberlake, PhD Kansas City VA Medical Center, Kansas City, MO

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01691027     History of Changes
Other Study ID Numbers: C1000-R
First Posted: September 24, 2012    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
scotoma, central
visual motor coordination

Additional relevant MeSH terms:
Vision Disorders
Vision, Low
Scotoma
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms